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Clinical Trial Summary

The goal of this observational study is to collect health data on people who are at high risk of having heart complications and are having a surgery that is not on the heart. The main questions it aims to answer are: - Is this study feasible in terms of recruiting enough people to participate in this study? - How often do heart complications happen in people who are at high risk of heart complications and are having a surgery that is not on the heart? Participants will have their usual care and will also be asked to: - Have extra bloodwork done - Complete some surveys - Have two echocardiograms (ultrasounds of the heart) - Continue to follow-up with the research team for one year after their surgery Researchers will compare how often heart complications occur in this high risk population to a future study where participants will receive stem cells before their surgery.


Clinical Trial Description

This observational trial protocol is to collect baseline health data from participants undergoing intermediate to high-risk surgery and at high risk of developing perioperative myocardial ischemic complications for an upcoming Phase 1 trial that determines the feasibility of intravenous delivery of umbilical cord-derived (UC) mesenchymal stromal cells (MSCs) in the same patient population. Participants enrolled in this protocol, however, will not receive cell product; they will receive standard of care and serve as a lead in control group for the interventional study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05762601
Study type Observational
Source Ottawa Hospital Research Institute
Contact Meredith Conboy, MSc
Phone 613-737-8899
Email mconboy@ohri.ca
Status Recruiting
Phase
Start date February 15, 2023
Completion date September 2025

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